chronic obstructive pulmonary disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: REVINTY ELLIPTA - 92 MICROGRAMMI/22 MICROGRAMMI - POLVERE PER INALAZIONE, PRE-DOSATA - USO INALATORIO - BLISTER (ALU) - 1 INALATORE DA 30 DOSI
Product Name: fluticasone furoato vilanterol
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be older than 60 years of age, at the time of signing the informed consent. 2. Recently (within 6 months) discharged from hospital with a diagnosis of acute exacerbation of COPD (usually coded as DRG 087 or DRG 088). 3. Participants with a clinical diagnosis of COPD (i.e. previous diagnosis of COPD and/or treatment with short acting bronchodilators (SABD), LABD or LABD+ICS) 4. Spirometry confirmed diagnosis of COPD, post-bronchodilator (30 minutes after 400 µg salbutamol) FEV1/FVC ratio 10 pack years (a pack year is defined as 20 cigarettes smoked every day for a year) 6. Clinical diagnosis documented in the patient’s medical records of one or more major chronic cardiac disease (heart failure, ischemic heart disease or atrial fibrillation). 7. Currently receiving at least one of the specified treatments (either alone or in combination, see Appendix 10.5) for heart failure, ischemic heart disease or atrial fibrillation. 8. Participant must be willing and able to perform pulmonary function tests 9. Male or female. Contraception is not considered necessary in this cohort of elderly (> 60 years) patients receiving treatment with commercially available licensed products. 10. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 927
Exclusion criteria
Exclusion criteria: 1. Patients with a primary discharge diagnosis of DRG 087 or DRG 088 but clearly judged by the clinical investigator to be due to other causes, i.e. patients presenting to the hospital with symptoms of AECOPD but due mainly to other conditions (pulmonary embolism, pneumonia, pneumothorax, anemia, acute kidney failure, decompensated heart failure, acute ischemic heart disease, new onset atrial fibrillation, stroke, etc.) 2. Patients who required invasive mechanical ventilation during hospitalization 3. Patients with Asthma as primary and principal diagnosis 4. Patients with severe cardiovascular (CV) disease who in the opinion of the investigator are unlikely to survive the 15 month study period 5. Patients considered unable to comply with the study procedures and follow-up in the opinion of the investigator (eg, evidence of alcohol or drug abuse, psychiatric disorder, physical disability, social or geographical obstacles) 6. Patients in whom spirometry is contraindicated (eg, hemoptysis, detached retina, active tuberculosis, last trimester of pregnancy) 7. Patients with other mechanical or overt causes of respiratory symptoms, particularly dyspnea (such as pneumothorax, chest wall trauma, lung fibrosis, lung cancer, anemia, severe obesity (BMI >40) or cachexia (BMI <18)) 8. Patients with any major disease which in the opinion of the investigator would prevent study participation, such as dementia, end-stage disease, cachexia, chronically bedridden patient and life expectancy <15 months. 9. Participation in any other interventional study within the last 3 months or concurrent participation in an observational clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •to demonstrate that in chronically symptomatic elderly COPD GOLD D patients with one or more cardiac comorbidities (heart failure, and/or ischemic heart disease, and/or atrial fibrillation) who have been recently hospitalized due to AECOPD, 1-years treatment with LABD+ICS will prolong the time to first re-hospitalization and/or the death for any cause when compared to 1-years treatment with LABD alone;Secondary Objective: •to compare the number of moderate/severe exacerbations of COPD in the two patient groups •to compare the number of re-hospitalizations and deaths (all cause) in the two patient groups •to compare quality of life (QoL) scores measured using the COPD Assessment Test (CAT) and mMRC dyspnoea scale between the two patient groups •to verify if one year of treatment with combination therapy including ICS increases the risk of pneumonia •to compare the number of acute cardiac events in this frail, elderly COPD population •to compare the incidence of deaths due to cardiovascular events •to compare changes in lung function ;Primary end point(s): •composite event of the time to first re-hospitalization and/or death (all cause);Timepoint(s) of evaluation of this end point: During the 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): number of moderate/severe COPD exacerbations; number of re-hospitalizations and deaths (all cause); QoL variation measured as change in CAT total score from baseline to end of treatment period.; change in mMRC dyspnea score from baseline to end of treatment period.; number of pneumonia events; number of acute cardiac events; number of cardiovascular deaths; • change in FEV1 from baseline to the end of treatment period; • change in FVC from baseline to the end of treatment period;Timepoint(s) of evaluation of this end point: During the 12 months of treatment; During the 12 months of treatment; at 3, 6, 9, 12 months; at 3,6,9, 12 months; During the 12 months of treatment; During the 12 months of treatment; During the 12 months of treatment; during the 12 months of treatment; during the 12 months of treatment | — |
Countries
Italy
Contacts
Public ContactFabio Gambini
CrosNT
Outcome results
None listed